Kenji Umayahara1, Munetaka Takekuma2, Yasuyuki Hirashima2, Shin-Ei Noda3, Tatsuya Ohno3, Etsuko Miyagi4, Fumiki Hirahara4, Eiji Hirata5, Eiji Kondo6, Tsutomu Tabata6, Yutaka Nagai7, Yoichi Aoki7, Masaru Wakatsuki8, Masahiro Takeuchi9, Takafumi Toita10, Nobuhiro Takeshima11, Ken Takizawa11. 1. Department of Gynecology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan. Electronic address: kenji.umayahara@jfcr.or.jp. 2. Department of Gynecology, Shizuoka Cancer Center, Shizuoka, Japan. 3. Department of Radiation Oncology, Gunma University Hospital, Gunma, Japan. 4. Department of Obstetrics and Gynecology, Yokohama City University Hospital, Yokohama, Japan. 5. Department of Obstetrics and Gynecology, Hiroshima University Hospital, Hiroshima, Japan. 6. Department of Obstetrics and Gynecology, Mie University Hospital, Mie, Japan. 7. Department of Obstetrics and Gynecology, Ryukyus University Hospital, Okinawa, Japan. 8. Research Center for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan. 9. Department of Clinical Medicine (Biostatistics & Pharmaceutical Medicine), School of Pharmacy, Kitasato University, Tokyo, Japan. 10. Department of Radiology, Ryukyus University Hospital, Okinawa, Japan. 11. Department of Gynecology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Abstract
OBJECTIVE: A multicenter phase II trial was conducted to assess the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) with weekly cisplatin (CDDP) and paclitaxel (PTX) in patients with locally advanced uterine cervical cancer. METHODS: Patients with FIGO stage III-IVA uterine cervical cancer without para-aortic lymphadenopathy were enrolled. Patients received definitive radiotherapy (RT) consisting of external beam whole-pelvic RT and high-dose-rate intracavitary brachytherapy. The cumulative linear quadratic equivalent dose was 62-65Gy prescribed at point A. weekly CDDP at 30mg/m(2) and PTX at 50mg/m(2) were administered concurrently with RT for ≥5 courses. RESULTS: Sixty-eight of the 70 registered patients were eligible. The complete response rate was 76.5% (95% confidence interval [CI], 66.4-86.6%). With a median follow-up of 27months (range, 7.9-33.5), the 2-year cumulative progression-free survival and the 2-year cumulative overall survival rates were 83.8% (95% CI, 75.1-92.6%) and 92.7% (95% CI, 86.4-98.9%), respectively. The pelvic cumulative disease progression-free and the 2-year cumulative distant metastasis rates were 89.6% (95% CI, 82.3-96.9%) and 13.2% (95% CI, 5.2-21.3%), respectively. The 2-year cumulative late complication rates were 25% for all grades, 13.2% for grade 1, 5.9% for grade 2, 2.9% for grade 3, and 2.9% for grade 4. CONCLUSIONS: For locally advanced cervical cancer, CCRT with weekly CDDP 30mg/m(2) and PTX at 50mg/m(2) demonstrated favorable antitumor activity, and was feasible and safe with respect to the protocol-specified serious adverse reactions and events. Evaluation of this regimen in phase III trials is warranted.
OBJECTIVE: A multicenter phase II trial was conducted to assess the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) with weekly cisplatin (CDDP) and paclitaxel (PTX) in patients with locally advanced uterine cervical cancer. METHODS:Patients with FIGO stage III-IVA uterine cervical cancer without para-aortic lymphadenopathy were enrolled. Patients received definitive radiotherapy (RT) consisting of external beam whole-pelvic RT and high-dose-rate intracavitary brachytherapy. The cumulative linear quadratic equivalent dose was 62-65Gy prescribed at point A. weekly CDDP at 30mg/m(2) and PTX at 50mg/m(2) were administered concurrently with RT for ≥5 courses. RESULTS: Sixty-eight of the 70 registered patients were eligible. The complete response rate was 76.5% (95% confidence interval [CI], 66.4-86.6%). With a median follow-up of 27months (range, 7.9-33.5), the 2-year cumulative progression-free survival and the 2-year cumulative overall survival rates were 83.8% (95% CI, 75.1-92.6%) and 92.7% (95% CI, 86.4-98.9%), respectively. The pelvic cumulative disease progression-free and the 2-year cumulative distant metastasis rates were 89.6% (95% CI, 82.3-96.9%) and 13.2% (95% CI, 5.2-21.3%), respectively. The 2-year cumulative late complication rates were 25% for all grades, 13.2% for grade 1, 5.9% for grade 2, 2.9% for grade 3, and 2.9% for grade 4. CONCLUSIONS: For locally advanced cervical cancer, CCRT with weekly CDDP 30mg/m(2) and PTX at 50mg/m(2) demonstrated favorable antitumor activity, and was feasible and safe with respect to the protocol-specified serious adverse reactions and events. Evaluation of this regimen in phase III trials is warranted.